CLINICAL TRIAL

HEIGHT RT for Prostate Cancer

Recruiting · 18+ · Male · Miami, FL

This study is evaluating whether a higher dose of radiation may help control prostate cancer while reducing the amount of radiation to nearby organs.

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About the trial for Prostate Cancer

Eligible Conditions
Prostatic Neoplasms · Prostate Cancer

Treatment Groups

This trial involves 2 different treatments. HEIGHT RT is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
LEAD RT
RADIATION
Experimental Group 2
HEIGHT RT
RADIATION

Eligibility

This trial is for male patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
D. Gleason score 6-10.
i. It may be initiated no more than 3 months prior to the signing of consent
ii. It must be started prior to the start of radiotherapy
iii. The total length planned must be ≤ 30 months
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 5.25 years (post-treatment)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 5.25 years (post-treatment).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether HEIGHT RT will improve 1 primary outcome and 9 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of 3 months post-RT, 9-months post-RT, within 3 months of 2-2.5 post-treatment biopsy.

Correlation between Pathologic Complete Response (PathCR) and Changes in serial post-RT MRIs
3 MONTHS POST-RT, 9-MONTHS POST-RT, WITHIN 3 MONTHS OF 2-2.5 POST-TREATMENT BIOPSY
To establish the relationship between PathCR and changes in serial post-RT MRI's obtained at 3 months and 9 months after RT, and within 3 months prior to the primary endpoint post-treatment prostate biopsy at 2.0-2.5 yr after completion of all therapy.
Change in CCAF Levels
BASELINE (PRE-TREATMENT), UP TO 2 YEARS (POST-TREATMENT)
Circulating Cancer Associated Fibroblasts (CCAF) levels evaluated from peripheral blood samples.
Change in CTC Levels
BASELINE (PRE-TREATMENT), UP TO 2 YEARS (POST-TREATMENT)
Circulating Tumor Cell (CTC) levels evaluated from peripheral blood samples.
Number of participants experiencing treatment related adverse events
UP TO 2 YEARS
Number of participants experiencing acute and late toxicity will be evaluated by treating physicians
Rate of Prostate Tumor PathCR
UP TO 3 YEARS
Prostate Tumor Pathologic Complete Response (PathCR) will be measured using standard ultrasound guided systematic prostate biopsy.
Change in gene/biomarker expression
BASELINE, UP TO 5.25 YEARS (POST-TREATMENT)
Change in gene/biomarker expression in different MP-MRI tumor regions assessed from prostate biopsy samples.
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Who is running the study

Principal Investigator
A. P.
Prof. Alan Pollack,, MD PhD
University of Miami

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for prostate cancer?

Treatment options for prostate cancer include surgery, radiation therapy and adjunctive medication. There are no studies investigating what the combination of treatments is best for patients. Treatment options should be tailored to the individual characteristics of each man.

Anonymous Patient Answer

How many people get prostate cancer a year in the United States?

It is estimated that there are approximately 518,000 men with a history of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) among a population that is aged 40 and older. Given the number of new cancer diagnoses at each American state every year, these findings suggest that more than 1 in 5 men in the United States who now have prostate cancer do so annually. This is consistent with the incidence of prostate cancer observed in North American populations.

Anonymous Patient Answer

Can prostate cancer be cured?

Even with new, more effective treatment, prostate cancer cannot be cured. Nevertheless, even with advanced disease and/or low volume disease, a high degree of cure can be expected after successful therapy in certain high-risk patient groups.

Anonymous Patient Answer

What causes prostate cancer?

It has been found that there are several genetic and environmental risk factors that can be affected by obesity, but not all of the causes of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) are known. Cancer.

Anonymous Patient Answer

What are the signs of prostate cancer?

The presence and characteristics of symptoms are the main determinants for PCa diagnosis even if the prostate tumor is small and is unlikely to cause any symptoms.

Anonymous Patient Answer

What is prostate cancer?

While there are many theories explaining what a [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is, no one single theory is completely accepted. It is important to take into account that for prostate cancer there are no definitive treatment options. The first step in getting treatment is to diagnose the disease that has impacted the cancer patient. It is crucial to diagnose the cancer that is present as early as possible and to notify their doctors regarding the seriousness of the condition. Patients with prostate cancer have many options to treatment but none are permanent. Treatment for prostate cancer revolves around the quality of life that must be balanced with risks and burdens associated with treatment.

Anonymous Patient Answer

Does height rt improve quality of life for those with prostate cancer?

Height >190 cm improved the quality of life of the survivors for a mean of 8.2 months and 10.9 months for men with a height >185 cm and >190 cm, respectively. Height >190 cm was associated with a better quality of life for both the short term (p<0.0001) and long term.

Anonymous Patient Answer

Who should consider clinical trials for prostate cancer?

Clinical trials do not appear to be a viable option for most men with localized prostate cancer for whom surgical treatment is preferable, provided the disease status is good and a course of active surveillance is tolerated.

Anonymous Patient Answer

Has height rt proven to be more effective than a placebo?

Findings from a recent study of this study show no superiority of height (about 5 cm, compared with 4 cm of the conventional BPH treatment regimens) over a placebo to improve symptoms, HRQL, urinary parameters and prostate-specific antigen in a randomized controlled trial of men having BPH.

Anonymous Patient Answer

Have there been other clinical trials involving height rt?

We found only one other study on height and prostate cancer, including only 12 prostate cancer patients, with the group not receiving height treatment and no height outcome. This small trial found a significantly higher likelihood of early relapse for prostate cancer patients with height and therefore suggest that this may be related to height treatments. Nonetheless, as we only found two other studies, we cannot completely rule out a possible role of height treatment and prostate cancer.

Anonymous Patient Answer

What are the common side effects of height rt?

Height rt is associated with side effects in pediatric patients, but as in adults most are of minor clinical importance. On the other hand, short stature is associated with increased risk of thyroid and osteoporotic fractures.

Anonymous Patient Answer

How does height rt work?

It was concluded that, because of their relatively small sample size, and the limited range of the test scores, height cannot be regarded as useful as a screening tool to detect risk associated with prostate cancer.

Anonymous Patient Answer
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